Combination nucleosides no better than single-drug treatment for chronic HBV

Last Updated: 2006-06-14 17:47:59 -0400 (Reuters Health)

By Will Boggs, MD

NEW YORK (Reuters Health) - Treatment with emtricitabine in combination with clevudine offers no clinical advantage over emtricitabine alone for patients with chronic hepatitis B virus (HBV) infection, according to a report in the May issue of Antimicrobial Agents and Chemotherapy.

"I think this work (and other) indicates that there is probably no gain to combine the current nucleosides for the treatment of HBV," Dr. Franck Rousseau from Gilead Sciences, Inc., Durham, North Carolina told Reuters Health. "This study failed to demonstrate a benefit of the combination over the individual drugs."

Dr. Rousseau and colleagues note that emtricitabine, approved for the treatment of HIV, has activity against HBV, as does the investigational nucleoside analog clevudine. They compared the safety, efficacy, and tolerability of 24 weeks of treatment with emtricitabine (FTC) alone or in combination with clevudine (CLV) in 157 patients with chronic HBV infection.

Antiviral activity did not differ significantly between the two treatment arms after 24 weeks of treatment, the authors report. Similarly, there was no significant difference in serologic responses between the treatments.

Viremia with FTC resistance mutations not found at baseline was 9% overall and did not differ significantly between the combination and single-drug treatment groups, the researchers note.

Moreover, the incidence of adverse events did not differ significantly between treatments, the report indicates. None of the patients discontinued treatment because of an adverse event.

"Combination therapy probably has a role for the treatment of HBV but what combination still remains to be elucidated," Dr. Rousseau said. "We abandoned the development of clevudine over 2 years ago, and the rights have reverted to the original licensor Bukwang from South Korea," Dr. Rousseau added.